RECOMBINANT FACTOR VIII FORMULATIONS

摘要

Provided are liquid and lyophilized recombinant Factor VIII formulations, including formulations for polymer-conjugated FVIII such as PEGylated Factor VIII.

主权项

1. A rFVIII formulation comprising:
(a) a range of from about 1 mM to about 5 mM divalent cation; (b) a range of from about 150 mM to about 250 mM sodium chloride or potassium chloride; (c) a range of from about 50 ppm to about 200 ppm of a non-ionic surfactant; and (d) a range of from about 100 IU/ml to about 5000 IU/ml of a rFVIII, wherein the rFVIII comprises an amino acid sequence that has one or more non-cysteine residues in the amino acid sequence of SEQ ID NO: 3 replaced with cysteine residues such that at least one pair of cysteine residues creates a disulfide bond not found in wild type FVIII;  wherein the rFVIII formulation has a pH in a range of from about pH 6.0 to about pH 7.5.